FDA Emergency Use Authorization (EUA)

The FDA recommends new manufacturers obtain an EUA prior to sale / distribution of regulated products (i.e. N95 masks, surgical masks, ventilators). Please see Maker section for instructions on how to obtain EUA.

Liability and non-regulated Supplies

"FDA recognizes that, when alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available."-FDA Guidance

HHS issued a declaration under the PREP Act granting immunity from liability under state and federal law against all claims the “manufacture, testing, development, distribution, administration, and use” of a countermeasure that is aimed at responding to COVID-19. Individual practitioners and hospitals may choose to accept non-FDA cleared supplies at their own risk. Non-regulated face masks and shields are now commonly used in low-risk settings.

How can I help?

Houston has a strong and growing medical innovation community. With the outbreak of COVID-19, our community of engineers, doctors, nurses, scientists, developers, designers, and business leaders came together to address Houston needs, and we need your help!